698 - Single-center, Consecutive Series Study of the Use of a Novel Beta-tri...

#698 Single-center, Consecutive Series Study of the Use of a Novel Beta-tricalcium Phosphate and Platelet-rich Fibrin Matrix as a Bone Graft Substitute in Posterolateral Lumbar Fusion

Value and Outcomes in Spine Surgery

Poster Presented by: C. Dowe

Author(s):

C. Dowe (1)
T. Callanan (1)
A. Brecevich (1)
D. Shein (1)
C. Steiner (1)
F. Cammisa (1)
C. Abjornson (1)

(1) Hospital for Special Surgery, New York, NY, United States

Abstract

Background: There are over 400,000 lumbar procedures that include posterolateral fusion performed every year in the United States. With such a high number of procedures, the use of bone graft substitutes as alternatives to autogenous iliac crest bone graft (ICBG) in spine fusion is increasingly common to avoid complications associated with ICBG harvest. However, challenges surround the production of a synthetic material that maintains both the osteoinductive and osteoconductive properties of autograft. Beta-tricalcium phosphate (β-TCP) bone graft substitute is engineered to support bone growth and resorb at a rate consistent with new bone deposition, while growth factors derived from platelets have been shown to stimulate many cell types, including lines active in bone formation. The novel combination of β-TCP and concentrated platelet formulation seeks to mimic ICBG, while eliminating the complications associated with ICBG harvesting.

Purpose: The purpose of the study was to assess the radiographic fusion rate and efficacy of a novel combination of an FDA approved β-TCP bone graft substitute and Platelet Rich Fibrin Matrix (PRFM) in posterolateral spine fusion procedures.

Study Design/Setting: Researchers retrospectively analyzed consecutive patients with posterolateral fusion procedures from L1 to S1, performed using beta-tricalcium phosphate, platelet-rich fibrin matrix, and local bone. These procedures included one-level to three-level posterolateral fusions, performed by a single surgeon.

Patient Sample: 50 patients underwent primary instrumented fusion. 50% of patients were male and 50% of patients were female. The mean age of participants was 63 years.

Outcome Measures: Outcome measures were based on radiographic fusion at the patients' 1-year follow up, complications after surgery, and VAS scores. In order to be considered fused, patients needed to be given an A or B by at least two of the three independent evaluators, could not have a cobb angle difference of >5° or translation >3mm on flexion/extension films, and could not have any evidence of hardware breakage, screw haloing or pullout.

Methods: Posterolateral lumbar fusions (PLF) were performed on patients using β-TCP (Integra Mozaik™, Plainsboro, NJ) combined with platelet-rich fibrin matrix (PRFM)(Vertical Spine Fibrinet®, Vertical Spine, Red Bank, NJ) and local bone. Radiographic fusion was assessed by three independent orthopedic spine surgeons 1-year post-operation using plain radiographs and the Lenke scoring system (A to D):
(A) Fused, large bilateral fusion masses;
(B) Likely fused, large unilateral fusion mass with contralateral small mass;
(C) Likely not fused, thin fusion masses with cracks;
(D) Unfused, graft resorption or an obvious pseudoarthrosis.

Results: Radiographic fusion of all levels displayed a 92% rate in fusion outcomes, with a 96% success rate for males and 88% for females. While 91.6% of 1-level and 2-level fusion procedures successfully fused, 100% of 3-level procedures met our criteria for fusion. According to the VAS scales, results also indicated that patients experienced significant improvement in leg and back pain (p< .01). One complication was reported, however no patient required a revision surgery.

Conclusion: The combination of beta-tricalcium phosphate and PRFM as a bone graft substitute in posterior lumbar fusion procedures demonstrated noteworthy results (92% fusion rate). This rate is comparable to the “gold standard” of iliac crest bone graft, while eliminating complications associated with iliac crest bone graft harvesting.